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510(k) K913521

XEMEX TEMPORARY PACING CATHETER A MODIFIED by Zeon Medical Corp. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1991
Date Received
August 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Pacemaker, Temporary
Device Class
Class II
Regulation Number
870.3680
Review Panel
CV
Submission Type

Other clearances by Zeon Medical Corp.

  • K905573 — XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A (June 19, 1991)
  • K904868 — XEMEX TEMPORARY PACING CATHETER A (May 16, 1991)

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